Intervention to Reduce Body Burdens of PCBs in Residents of Anniston, Alabama

NCT01261338 | Completed Early Phase 1 Results

• 3 other identifiers: 10100801 1R21ES019206-011R21ES019206-018 UL1 TR00007
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Because of industrial pollution, a large number of people in Anniston, Alabama, have elevated body burdens of the class of compounds known as polychlorinated biphenyls (PCBs). There is evidence that these compounds are associated with risks to health including diabetes. There is also evidence that the consumption of a non-absorbable dietary fat can reduce the level of compounds like PCBs. This clinical trial will test the hypothesis that a non-absorbable dietary fat can reduce the levels of PCBs in subjects in Anniston.

Conditions

Toxic Effect of Other Corrosive Organic Compounds

Keywords

PCBs; Olestra

Outcome Measures

Primary Outcomes (2)

• Percent Change From Baseline for Total PCB Levels

  The outcome is the percent change in body burden of total PCB's measured over one year. Initially the percent of baseline is calculated as (value at one year / value at baseline) \*100, then this is examined modeling over time as compared to the 100% at baseline.

  one year

• Rate of Change of Lipid Adjusted PCB Levels

  This is a measure of the change in body burden of PCBs

  One year

Study Arms (2)

olestra

EXPERIMENTAL

Non-absorbable fat administered in the form of 24 potato crisps per day (12 each with mid-day and evening meal) providing approximately 15g/day of olestra.

Drug: olestra

Vegetable oil

PLACEBO COMPARATOR

Absorbable fat administered in the form of 12 potato crisps per day (6 each with mid-day and evening meal) in order to match the caloric intake provided by the crisps with Olestra.

Drug: olestra

Interventions

olestra DRUG

non-absorbable dietary fat

Also known as: Olean, non absorbable fat, fat substitute

Vegetable oil; olestra

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elevated blood level of PCBs

You may not qualify if:

• Pregnancy
• Breast-feeding
• Weight-loss medication
• Gastrointestinal disease

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator
• University of Cincinnati: collaborator

Study Sites (1)

West Anniston Foundation

Anniston, Alabama, 36201, United States

Location

Related Publications (1)

• Jandacek RJ, Heubi JE, Buckley DD, Khoury JC, Turner WE, Sjodin A, Olson JR, Shelton C, Helms K, Bailey TD, Carter S, Tso P, Pavuk M. Reduction of the body burden of PCBs and DDE by dietary intervention in a randomized trial. J Nutr Biochem. 2014 Apr;25(4):483-8. doi: 10.1016/j.jnutbio.2014.01.002. Epub 2014 Jan 29.

  PMID: 24629911 RESULT

MeSH Terms

Interventions

sucrose polyester; Fat Substitutes

Intervention Hierarchy (Ancestors)

Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Ronald J. Jandacek, PhD, Principal Investigator
• Organization: University of Cincinnati

ronald.jandacek@uc.edu

513-558-5492

Study Officials

• Ronald J Jandacek, Ph.D.

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 16, 2010
• Study Start: December 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 14, 2020
• Results First Posted: September 14, 2020

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)